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A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT01732380
Recruitment Status : Unknown
Verified November 2012 by The First People's Hospital of Lianyungang.
Recruitment status was:  Recruiting
First Posted : November 22, 2012
Last Update Posted : November 22, 2012
Sponsor:
Collaborators:
The East Hospital of Lianyungang
Donghai People's Hospital
People's Hospital of Ganyu
Information provided by (Responsible Party):
The First People's Hospital of Lianyungang

Tracking Information
First Submitted Date  ICMJE November 14, 2012
First Posted Date  ICMJE November 22, 2012
Last Update Posted Date November 22, 2012
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
Progression-Free-Survival [ Time Frame: up to 2 years ]
Progression-free survival (PFS) is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
Response Rate [ Time Frame: up to 2 years ]
Response rate (RR) is a figure representing the percentage of patients whose cancer shrinks (termed a partial response, PR) or disappears after treatment (termed a complete response, CR) . In simpler terms RR=PR+CR.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 19, 2012)
Overall survival [ Time Frame: up to 2 years ]
People in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer. The overall survival is often stated as a five-year survival, which means people in a study or treatment group who are alive five years after their diagnosis or the start of treatment.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
Official Title  ICMJE A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
Brief Summary The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.
Detailed Description 108 patients were randomized to receive Raltitrexed/Oxaliplatin Plus Radiotherapy (Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks.)or Radiotherapy ( Radiotherapy 2.0Gy/day, 5 times/week,6 weeks) in subjects with Inoperable esophageal cancer. All patients will receive therapy of six weeks unless disease progression or unacceptable toxicity. Patients were evaluated every 3 months .Progression-Free-Survival was the primary endpoint. Response Rate, Overall survival, toxicity of the therapy are other second endpoint.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Inoperable Esophageal Cancer Stage I-III
Intervention  ICMJE
  • Drug: Raltitrexed
    Other Names:
    • TOMUDEX
    • Sai Wei Jian
  • Drug: Oxaliplatin
    Other Name: Eloxatin
  • Radiation: Radiotherapy
Study Arms  ICMJE
  • Active Comparator: Radiotherapy
    Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
    Intervention: Radiation: Radiotherapy
  • Experimental: Raltitrexed/Oxaliplatin Plus Radiotherapy
    Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
    Interventions:
    • Drug: Raltitrexed
    • Drug: Oxaliplatin
    • Radiation: Radiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 19, 2012)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma)
  • Measurable disease according to RECIST criteria
  • Age > 18 years
  • WHO performance score < 2
  • Estimated life expectancy of > 12 weeks
  • Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
  • Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
  • Renal function: Cr ≤ 1.25×UNL
  • Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
  • Documented informed consent to participate in the trial

Exclusion Criteria:

  • Subjects with distant metastases
  • Pregnancy or breast feeding. Women of childbearing age must use effective contraception
  • Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
  • Evidence of bleeding diathesis or serious infection
  • pregnant or lactating woman
  • Patient participation in other studies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01732380
Other Study ID Numbers  ICMJE 1stPeopleLianyungang
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The First People's Hospital of Lianyungang
Study Sponsor  ICMJE The First People's Hospital of Lianyungang
Collaborators  ICMJE
  • The East Hospital of Lianyungang
  • Donghai People's Hospital
  • People's Hospital of Ganyu
Investigators  ICMJE
Study Chair: Xiaodong Jiang, Doctor The First People's Hospital of Lianyungang
PRS Account The First People's Hospital of Lianyungang
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP